NCT05321732

Brief Summary

This study aims to evaluate the pharmacokinetic and pharmacodynamic characteristics and safety of co-administration of DWP16001 2 mg and DWC202010 (DWC202010 37.5 mg) in healthy adults compared to the case of administration alone.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Dec 2021

Typical duration for phase_1 healthy-volunteers

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 16, 2022

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 11, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

April 11, 2022

Status Verified

January 1, 2022

Enrollment Period

8 months

First QC Date

January 16, 2022

Last Update Submit

April 4, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

  • Peak Plasma Concentration (Cmax,ss) of DWP16001

    Before IP administration of Day 1, Day 5, and Day 6

  • Area under the plasma concentration versus time curve (AUCtau,ss) of DWP16001

    Before IP administration of Day 1, Day 5, and Day 6

  • Peak Plasma Concentration (Cmax,ss) of DWC202010

    Before IP administration and post-dose up to 24 hours

  • Area under the plasma concentration versus time curve (AUCtau,ss) of DWC202010

    Before IP administration and post-dose up to 24 hours

Study Arms (3)

Intervention: DWP16001 A mg

EXPERIMENTAL
Drug: DWP16001

Intervention: DWC202010 B mg

EXPERIMENTAL
Drug: DWP202010

Intervention: DWP16001 A mg + DWC202010 B mg

EXPERIMENTAL
Drug: DWP16001Drug: DWP202010

Interventions

DWP16001DRUG

DWP16001 A mg

Intervention: DWP16001 A mgIntervention: DWP16001 A mg + DWC202010 B mg
DWP202010DRUG

DWP202010 B mg

Intervention: DWC202010 B mgIntervention: DWP16001 A mg + DWC202010 B mg

Eligibility Criteria

Age19 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei University Severance Hospital

Seoul, South Korea

Location

Related Publications (1)

  • Yoon S, Park MS, Jin BH, Shin H, Na J, Huh W, Kim CO. Pharmacokinetic and pharmacodynamic interaction of DWP16001, a sodium-glucose cotransporter-2 inhibitor, with phentermine in healthy subjects. Expert Opin Drug Metab Toxicol. 2023 Jul-Dec;19(7):479-485. doi: 10.1080/17425255.2023.2249397. Epub 2023 Aug 25.

    PMID: 37593838DERIVED

MeSH Terms

Interventions

Enavogliflozin

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2022

First Posted

April 11, 2022

Study Start

December 10, 2021

Primary Completion

August 1, 2022

Study Completion

August 1, 2022

Last Updated

April 11, 2022

Record last verified: 2022-01

Locations

KR(1)